Results of the prospective T-DIS randomized phase II trial comparing interruption versus continuation of trabectedin after six cycles of treatment in patients (pts) with advanced soft tissue sarcoma (ASTS).

10523 Background: Trabectedin (T) maintenance beyond 6 cycles (cy) of treatment in responding pts with ASTS is associated with improved outcomes (Retrospective on database analysis; ASCO 2013). Herein, the impact of T discontinuation on progression-free survival (PFS) and overall survival (OS) was prospectively analyzed by the French Sarcoma Group in a national non-comparative randomized phase II trial. Methods: After the initial 6 cy of T (1.5 mg/m² as 24-h infusion every 3 weeks), pts free from progressive disease (PD) were randomly assigned either to continuous treatment (C arm) or therapy interruption (I arm) with T. Pts who declined randomization could continue with T. Pts allocated to the I arm could restart T in case of PD. Primary endpoint was PFS rate at 6 months (m) weeks after randomization. Results: FromFebruary 2011 to March 2013, 178 pretreated pts have been enrolled. At inclusion, the pts had a median age of 57.5 years (range19-82) and a median performance status of 1 (range 0-3) and most h...